Virtual Library

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    Media Availability (ID 1003)

    • Event: WCLC 2018
    • Type: Press Conference
    • Track:
    • Presentations: 7
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 09:45 - 10:30, Plenary Hall
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      Summarize Plenary Themes/Key Results/News (ID 14881)

      09:45 - 09:50  |  Presenting Author(s): Andrea Bezjak

      • Abstract

      Abstract not provided

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      IMpower132: PFS and Safety Results with 1L Atezolizumab + Carboplatin/Cisplatin + Pemetrexed in Stage IV Non-Squamous NSCLC (Now Available) (ID 14885)

      09:50 - 09:55  |  Presenting Author(s): Vassiliki A Papadimitrakopoulou

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small Cell Lung Cancer (NSCLC) (Now Available) (ID 14886)

      09:55 - 10:00  |  Presenting Author(s): Robert C. Doebele

      • Abstract
      • Presentation
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      Abstract not provided

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      When Breath Becomes Air (ID 14880)

      10:00 - 10:05  |  Presenting Author(s): Lucy Kalanithi

      • Abstract

      Abstract not provided

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      Association Between Outdoor Air Pollution And Lung Cancer in Female Never Smokers (Now Available) (ID 14882)

      10:05 - 10:10  |  Presenting Author(s): Renelle L Myers

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

      Information from this presentation has been removed upon request of the author.

      Information from this presentation has been removed upon request of the author.

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      Case-Series Study in Ever- and Never-Smoking Females and Males with NSCLC: Exposures, Tumor Factors, Biology and Survival (SWOG S0424) (Now Available) (ID 14883)

      10:10 - 10:15  |  Presenting Author(s): Kathy S. Albain

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      Acceptance of Smoking Cessation Services in Cancer Care Ontario’s Lung Cancer Screening Pilot for People at High Risk (Now Available) (ID 14884)

      10:15 - 10:20  |  Presenting Author(s): William Kenneth Evans

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

      Information from this presentation has been removed upon request of the author.

      Information from this presentation has been removed upon request of the author.

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    Media Availability (ID 1004)

    • Event: WCLC 2018
    • Type: Press Conference
    • Track:
    • Presentations: 0
    • Moderators:
    • Coordinates: 9/26/2018, 09:45 - 10:30, Plenary Hall
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    ISS08 - Symposium Supported by Foundation Medicine: Implementing Liquid Biopsies into Clinical Practice: Challenges, Achievements and Progress (Not IASLC CME Accredited) (ID 999)

    • Event: WCLC 2018
    • Type: Industry Supported Symposia
    • Track:
    • Presentations: 3
    • Moderators:
    • Coordinates: 9/24/2018, 07:00 - 08:00, Plenary Hall
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      The Current State and Critical Role of Liquid Biopsy (ID 14808)

      07:05 - 07:20  |  Presenting Author(s): Nir Peled

      • Abstract

      Abstract not provided

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      Integrating Tissue - and Liquid - Based Approaches into Practice (ID 14809)

      07:20 - 07:35  |  Author(s): Ruben Cabanillas

      • Abstract

      Abstract not provided

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      The Future State of Liquid Biopsy (ID 14810)

      07:35 - 07:50  |  Presenting Author(s): Sai-Hong Ignatius Ou

      • Abstract

      Abstract not provided

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    ISS09 - Symposium Supported by Merck: Pembrolizumab: The Evolving Standard of Care in Advanced and Early-Stage Lung Cancer (Not IASLC CME Accredited) (ID 860)

    • Event: WCLC 2018
    • Type: Industry Supported Symposia
    • Track:
    • Presentations: 7
    • Moderators:
    • Coordinates: 9/24/2018, 12:00 - 13:30, Plenary Hall
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      Welcome and Introduction (ID 12162)

      12:00 - 12:00  |  Presenting Author(s): Quincy Chu

      • Abstract

      Abstract not provided

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      First- and Second-Line Use of Immune Checkpoint Inhibitor Monotherapy for Metastatic NSCLC (ID 14827)

      12:00 - 12:15  |  Presenting Author(s): Martin Reck

      • Abstract

      Abstract not provided

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      Combination Options in First-Line Metastatic NSCLC (ID 14828)

      12:15 - 12:30  |  Presenting Author(s): Silvia Novello

      • Abstract

      Abstract not provided

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      Future Utilization of Immunotherapy (ID 14829)

      12:30 - 12:45  |  Presenting Author(s): Quincy Chu

      • Abstract

      Abstract not provided

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      Patient Selection – Cases on the Use of Monotherapy, Chemotherapy/IO Combinations, and IO/IO Combinations (ID 14830)

      12:45 - 13:00  |  Presenting Author(s): Joachim G.J.V. Aerts

      • Abstract

      Abstract not provided

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      Panel Discussion (ID 14831)

      13:00 - 13:25  |  Presenting Author(s): Quincy Chu, Martin Reck, Silvia Novello, Joachim G.J.V. Aerts

      • Abstract

      Abstract not provided

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      Closing Remarks (ID 14832)

      13:25 - 13:30  |  Presenting Author(s): Quincy Chu

      • Abstract

      Abstract not provided

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    ISS14 - Symposium Supported by Novartis: Expert Perspectives on the Management of NSCLC in Clinical Practice: Are Novel Approaches Realistic? (Not IASLC CME Accredited) (ID 863)

    • Event: WCLC 2018
    • Type: Industry Supported Symposia
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 12:00 - 13:30, Plenary Hall
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      Symposium Supported by Novartis: Expert Perspectives on the Management of NSCLC in Clinical Practice: Are Novel Approaches Realistic? (ID 12166)

      12:00 - 13:30  |  Presenting Author(s): Daniel S.W. Tan, Scott A. Laurie, Laura Q Chow

      • Abstract
      • Slides

      Abstract not provided

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    ISS16 - Symposium Supported by AbbVie: Biomarker Driven SCLC Treatment: Fact or Fiction? (Not IASLC CME Accredited) (ID 867)

    • Event: WCLC 2018
    • Type: Industry Supported Symposia
    • Track:
    • Presentations: 5
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Plenary Hall
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      Introductions (ID 12170)

      12:00 - 12:05  |  Presenting Author(s): Peter Michael Ellis

      • Abstract

      Abstract not provided

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      Expanding options in treatment of SCLC: Unmet needs and new targets (ID 14819)

      12:05 - 12:25  |  Presenting Author(s): Peter Michael Ellis

      • Abstract

      Abstract not provided

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      Incorporating biomarker testing in SCLC patient evaluation: Current challenges and lessons learned from NSCLC (ID 14820)

      12:25 - 12:50  |  Presenting Author(s): Philippe Joubert

      • Abstract

      Abstract not provided

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      Changing treatment paradigm in SCLC: Emerging data on use of biomarkers in SCLC treatment (ID 14821)

      12:50 - 13:20  |  Presenting Author(s): David P Carbone

      • Abstract

      Abstract not provided

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      Panel discussion and Closing remarks (ID 14822)

      13:20 - 13:30  |  Presenting Author(s): Peter Michael Ellis, Philippe Joubert, David P Carbone

      • Abstract

      Abstract not provided

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    OC01 - Opening Ceremony (ID 839)

    • Event: WCLC 2018
    • Type: Opening Ceremony
    • Track:
    • Presentations: 4
    • Now Available
    • Moderators:
    • Coordinates: 9/23/2018, 19:00 - 20:30, Plenary Hall
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      OC01.01 - Welcome Addresses (ID 14928)

      19:00 - 19:30  |  Presenting Author(s): General Presenter

      • Abstract

      Abstract not provided

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      OC01.02 - Global Effects of Smoking, of Quitting, and of Taxing Tobacco on Lung Cancer and Other Diseases (Now Available) (ID 11596)

      19:30 - 19:45  |  Presenting Author(s): Prabhat Jha

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      OC01.03 - IASLC Distinguished Award Presentations (ID 14929)

      19:45 - 20:20  |  Presenting Author(s): General Presenter

      • Abstract

      Abstract not provided

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      OC01.04 - WCLC 2018 – At a Glance (ID 14930)

      20:20 - 20:30  |  Presenting Author(s): General Presenter

      • Abstract

      Abstract not provided

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    PL01 - Patients First (ID 849)

    • Event: WCLC 2018
    • Type: Plenary Session
    • Track:
    • Presentations: 6
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 08:15 - 09:45, Plenary Hall
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      PL01.01 - When Breath Becomes Air (Now Available) (ID 11643)

      08:15 - 08:25  |  Presenting Author(s): Lucy Kalanithi

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      PL01.02 - Science that Matters (Now Available) (ID 11644)

      08:25 - 08:40  |  Presenting Author(s): David P Carbone

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      PL01.03 - Trials that Matter! (Now Available) (ID 11645)

      08:40 - 08:55  |  Presenting Author(s): Tony S. Mok

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      PL01.04 - Getting Drugs to Patients Faster: A Global View (Now Available) (ID 11646)

      08:55 - 09:10  |  Presenting Author(s): Solange Peters

      • Abstract
      • Presentation
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      Abstract not provided

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      PL01.05 - Conquering Lung Cancer - The IASLC Vision (Now Available) (ID 11647)

      09:10 - 09:25  |  Presenting Author(s): Giorgio Vittorio Scagliotti

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      PL01.06 - Patients First (Now Available) (ID 11648)

      09:25 - 09:40  |  Presenting Author(s): Tish Vigna

      • Abstract
      • Presentation

      Abstract not provided

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    PL02 - Presidential Symposium - Top 5 Abstracts (ID 850)

    • Event: WCLC 2018
    • Type: Plenary Session
    • Track: Advanced NSCLC
    • Presentations: 10
    • Now Available
    • Moderators:
    • Coordinates: 9/25/2018, 08:15 - 09:45, Plenary Hall
      • Abstract
      • Presentation
      • Slides

      Background

      In the global, Phase 3 PACIFIC study (Antonia 2017; NCT02125461), durvalumab significantly improved progression-free survival (PFS) versus placebo in Stage III, unresectable NSCLC patients without progression after chemoradiotherapy (CRT) (stratified HR, 0.52; 95% CI, 0.42–0.65; P<0.001). This was the first major advance in this disease setting for many years. Here we report the second primary endpoint overall survival (OS) for PACIFIC.

      Patients with WHO PS 0/1 (any PD-L1 tumor status) who received ≥2 cycles of platinum-based CRT were randomized (2:1) 1–42 days post-CRT to durvalumab 10 mg/kg IV Q2W or placebo up to 12 months, stratified by age, sex, and smoking history. Primary endpoints were PFS from randomization (blinded independent central review; RECIST v1.1) and OS (interim analysis reported). Secondary endpoints included time to death or distant metastasis (TTDM) and PFS2 (time to second progression) from randomization and safety. Time to first/second subsequent therapy or death (TFST/TSST) were supportive assessments for PFS/PFS2.

      Between May 2014 and April 2016, 713 patients were randomized of whom 709 received treatment (durvalumab, n=473; placebo, n=236). As of March 22, 2018 (data cutoff), median follow-up duration was 25.2 months (range, 0.2–43.1). After discontinuation, 41.0% and 54.0% in the durvalumab and placebo groups received subsequent anticancer therapy; overall, 8.0% and 22.4% received additional immunotherapy. Durvalumab significantly improved OS versus placebo (stratified HR 0.68, 99.73% CI, 0.469–0.997; P=0.00251), with the median not reached (NR; 95% CI, 34.7 months–NR) and 28.7 months (95% CI, 22.9–NR), respectively. Durvalumab improved OS in all pre-specified subgroups. Updated PFS remained similar (stratified HR 0.51, 95% CI, 0.41–0.63), with medians of 17.2 and 5.6 months with durvalumab and placebo, respectively. Durvalumab improved the updated TTDM (stratified HR 0.53, 95% CI, 0.41–0.68), as well as PFS2 (stratified HR 0.58, 95% CI, 0.46–0.73), TFST (stratified HR 0.58, 95% CI, 0.47–0.72) and TSST (stratified HR 0.63, 95% CI, 0.50–0.79). Within the durvalumab and placebo groups, 30.5% and 26.1% had grade 3/4 any-causality AEs, 15.4% and 9.8% discontinued due to AEs, and no new safety signals were identified.

      Durvalumab demonstrated statistically significant and clinically meaningful improvement in OS compared with placebo, supported by secondary endpoints such as PFS2. PACIFIC is the first study to show a survival advantage following CRT in this population, providing compelling evidence for the unprecedented benefit of durvalumab treatment as the standard of care.

      a9ded1e5ce5d75814730bb4caaf49419

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      PL02.02 - Discussant - PL02.01 (Now Available) (ID 14736)

      08:25 - 08:30  |  Presenting Author(s): Everett E Vokes

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      PL02.03 - Brigatinib vs Crizotinib in Patients With ALK Inhibitor-Naive Advanced ALK+ NSCLC: First Report of a Phase 3 Trial (ALTA-1L) (Now Available) (ID 11155)

      08:30 - 08:40  |  Presenting Author(s): Ross Camidge  |  Author(s): Hye Ryun Kim, Myung-Ju Ahn, James Chih-Hsin Yang, Ji-Youn Han, Jong-Seok Lee, Maximilian Johannes Hochmair, Jacky Yu-Chung Li, Gee-Chen Chang, Ki Hyeong Lee, Cesare Gridelli, Angelo Delmonte, Maria Rosario Garcia Campelo, Dong-Wan Kim, Alessandra Bearz, Frank Griesinger, Alessandro Morabito, Enriqueta Felip, Raffaele Califano, Sharmistha Ghosh, Alexander Spira, Scott N. Gettinger, Marcello Tiseo, Jeff Haney, David Kerstein, Sanjay Popat

      • Abstract
      • Presentation
      • Slides

      Background

      Brigatinib has robust efficacy in crizotinib-resistant ALK+ NSCLC, exhibiting median progression-free survival (mPFS) of 16.7 months. We report results of the first interim analysis from the ALTA-1L study of brigatinib vs crizotinib in ALK TKI-naive, ALK+ NSCLC (NCT02737501).

      This open-label, multicenter study enrolled patients with stage IIIB/IV ALK+ NSCLC based on local ALK testing (FDA approved/other). Eligible patients had ECOG PS 0–2, ≤1 prior systemic therapy for locally advanced/metastatic NSCLC, and no prior ALK inhibitor. Asymptomatic CNS metastases were allowed. All patients had systematic CNS imaging. Patients were randomized 1:1 to brigatinib 180 mg QD with 7-day lead-in at 90 mg or crizotinib 250 mg BID. Primary endpoint: blinded independent review committee (BIRC)-assessed PFS (RECIST v1.1). Secondary efficacy endpoints included BIRC-assessed objective response rate (ORR), intracranial ORR (iORR), and intracranial PFS (iPFS). Interim analyses were planned at 50% and 75% of planned PFS events (n=198).

      275 patients were randomized (brigatinib/crizotinib, n=137/138); median age (years) 58/60. 26%/27% received prior chemotherapy for advanced disease, and 29%/30% had baseline brain metastases. At data cut-off (19 February 2018), median follow-up brigatinib/crizotinib: 11.0/9.25 months; with 99 PFS events, brigatinib met the prespecified threshold for statistical superiority vs crizotinib in the primary endpoint, BIRC-assessed PFS (HR 0.49, 95% CI 0.33–0.74, log-rank P=0.0007); brigatinib mPFS was not reached (95% CI NR–NR) vs crizotinib 9.8 months (95% CI 9.0–12.9). Investigator-assessed PFS HR 0.45 (95% CI 0.30–0.68), log-rank P=0.0001. Table shows additional efficacy data. Most common treatment-emergent AEs grade ≥3: brigatinib: increased CPK (16.2%), increased lipase (13.2%), hypertension (9.6%); crizotinib: increased ALT (9.5%), AST (5.8%), and lipase (5.1%). Any grade ILD/pneumonitis: brigatinib, 3.7%; crizotinib, 2.2%. Discontinuations due to AE (brigatinib/crizotinib): 11.8%/8.8%.

      Brigatinib showed a statistically and clinically significant improvement in PFS compared with crizotinib in ALK inhibitor–naive ALK+ NSCLC.

      BIRC-Assessed Endpoint, %

      Brigatinib

      (n=137)

      Crizotinib

      (n=138)

      P-Value
      All patients
      ORRa 76 (68–83b) 73 (65–80b)
      Confirmed ORR 71 (62–78b) 60 (51–68b) 0.0678
      With any intracranial CNS metastases
      (n=43) (n=47)
      iORRa 79 (64–90b) 23 (12–38b)
      Confirmed iORR 67 (51–81b) 17 (8–31b) <0.0001
      Median iPFS, months NR (11–NRb) 6 (4–9b)
      1-year iPFS 67 (47–80b) 21 (6–42b)
      HR 0.27 (0.13–0.54) <0.0001c
      With measurable intracranial CNS metastases
      (n=18) (n=21)
      iORRa 83 (59–96b) 33 (15–57b)
      Confirmed iORR 78 (52–94b) 29 (11–52b) 0.0028
      aResponse, ≥1 assessment; b95% CI; cLog-rank.

      a9ded1e5ce5d75814730bb4caaf49419

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      PL02.04 - Discussant - PL02.03 (Now Available) (ID 14737)

      08:40 - 08:45  |  Presenting Author(s): Fiona Blackhall

      • Abstract
      • Presentation
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      Abstract not provided

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      PL02.05 - Effects of Volume CT Lung Cancer Screening: Mortality Results of the NELSON Randomised-Controlled Population Based Trial (Now Available) (ID 14722)

      08:45 - 08:55  |  Presenting Author(s): Harry J De Koning  |  Author(s): Carlijn M. Van Der Aalst, Kevin ten Haaf, Matthijs Oudkerk

      • Abstract
      • Presentation
      • Slides

      Abstract

      The NELSON-trial is a population-based RCT using nodule volume management for referral, initiated to show a 25% LC mortality reduction in males at 10-years of follow-up.

      606,409 persons, aged 50-74, in the Netherlands and Leuven were sent a general questionnaire about risk factors, leading to 150,920 responders. 30,959 responders were eligible and invited to participate, of which 15,822 gave informed consent and were randomized (1:1). CT-screening was offered to study arm participants at baseline and 1, 3 and 5.5 years after randomization, whereas no screening was offered to control arm participants. Participant’s records were linked to national registries with 100% coverage regarding cancer diagnosis (Netherlands Cancer Registry), date of death (Centre for Genealogy) and cause of death (Statistics Netherlands). Medical files for deceased lung cancer patients up to 2013 were reviewed by an expert panel (blinded to study arm); cause of death reported by Statistics Netherlands was used thereafter. Follow up to 31.12.2015 comprised a minimum duration of 10 years for 98.7% enrolled (unless deceased). A pre-determined 9-year analysis was also considered due to dilution effects by screening design given growth rate of LC.

      CT screening compliance was 94% on average, leading to a total of 29,736 scans. In 9.1% of the participants additional CT scans within 2 months were performed to estimate nodule Volume Doubling Time, leading to an overall referral rate of 2.1% for suspicious nodules. Detection rates across the rounds varied between 0.8-1.0%, and 69% of screen-detected LC were detected at stage IA or B. 261 lung cancers (52 interval cancers) were detected before the 4th round. In a subset of analyzed patients, surgical treatment was 3 times significantly more prevalent in study LC patients than in control arm patients (67.7% versus 24.5%, p<0,001). In total 934 participants have died in the control arm (NL), versus 904 in the study arm (NL). In the Dutch female enrolled participants, the rate-ratio of dying from lung cancer was 0.73 at 10-years, and 0.58 at 9-years FU.

      The minimum 10-year FU for NELSON has been realized, and full data on incidence, mortality and cause of death are equally available for both arms. A (non- significant) 41.8% lung cancer mortality reduction has been achieved in the small subset of 2,382 Dutch women. Post-hoc analysis shows a 51.4% (p=0.04) LC mortality reduction at 8 years of FU. Data for the full cohort will be presented on behalf of NELSON-investigators.

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      PL02.06 - Discussant - PL02.05 (Now Available) (ID 14738)

      08:55 - 09:00  |  Presenting Author(s): John Kirkpatrick Field

      • Abstract
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      Abstract not provided

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      PL02.07 - IMpower 133: Primary PFS, OS and Safety in a PH1/3 Study of 1L Atezolizumab + Carboplatin + Etoposide in Extensive-Stage SCLC (Now Available) (ID 12892)

      09:00 - 09:10  |  Presenting Author(s): Stephen V Liu  |  Author(s): Aaron S. Mansfield, Aleksandra Szczesna, Libor Havel, Maciej Krzakowski, Maximilian Johannes Hochmair, Florian Huemer, Gyorgy Losonczy, Melissa L. Johnson, Makoto Nishio, Martin Reck, Tony S. Mok, Sivuonthanh Lam, David S. Shames, Juan Liu, Beiying Ding, Fairooz Kabbinavar, Wei Lin, Alan Sandler, Leora Horn

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      Background

      First-line (1L) standard-of-care treatment for extensive-stage small cell lung cancer (ES-SCLC) is platinum (carboplatin or cisplatin) with etoposide. Despite high initial response rates, there has been limited progress in the last two decades and outcomes remain poor with a median overall survival (OS) of ~10 months. IMpower133 (NCT02763579), a global Phase 1/3, double-blind, randomized, placebo-controlled trial evaluated efficacy and safety of adding atezolizumab, a humanized monoclonal anti–PD-L1 antibody, or placebo to 1L carboplatin and etoposide in ES-SCLC.

      Patients with measurable (RECIST v1.1) ES-SCLC, ECOG performance status 0 or 1, who had not received prior systemic treatment for ES-SCLC were enrolled. PD-L1 immunohistochemical testing was not required. Patients were randomized 1:1 to receive four 21-day cycles of carboplatin (AUC 5 mg/mL/min IV, Day 1) plus etoposide (100 mg/m2 IV, Days 1-3) with either atezolizumab (1200 mg IV, Day 1) or placebo, followed by maintenance therapy with atezolizumab or placebo until intolerable toxicity or progressive disease per RECIST v1.1. Patients meeting predefined criteria could receive treatment beyond progression. Co-primary endpoints were OS and investigator-assessed progression-free survival (PFS). Adverse events (AEs) were graded per NCI-CTCAE v4.0. Blood-based tumor mutation burden (bTMB) was assessed using prespecified cutoffs of ≥16 vs. <16 and ≥10 vs. <10 mutations/Mb.

      In total, 201 patients were randomized to the atezolizumab group, and 202 to the placebo group. Median follow-up was 13.9 months. Median OS was 12.3 months in the atezolizumab group and 10.3 months in the placebo group (hazard ratio [HR] 0.70 [95% confidence interval (CI): 0.54, 0.91; P=0.0069]). Median PFS was 5.2 months and 4.3 months, respectively (HR 0.77 [95% CI: 0.62, 0.96; P=0.017]). OS and PFS benefits were consistent across key patient subgroups. Investigator-assessed confirmed objective response rates were 60.2% and 64.4% in the atezolizumab and placebo groups, respectively; median duration of response, 4.2 and 3.9 months. Exploratory analyses showed OS survival benefits in subgroups above and below prespecified bTMB cutoffs. Grade 3-4 treatment-related AEs were reported in 56.6% vs. 56.1% patients in atezolizumab vs. placebo groups, respectively; serious treatment-related AEs occurred in 22.7% and 18.9% patients, respectively.

      Addition of atezolizumab to carboplatin and etoposide provided a significant improvement in OS and PFS in 1L ES-SCLC in an all-comer patient population. No unexpected safety signals were identified. Atezolizumab plus carboplatin and etoposide may represent a new standard regimen for patients with untreated ES-SCLC.

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      PL02.08 - Discussant - PL02.07 (Now Available) (ID 14739)

      09:10 - 09:15  |  Presenting Author(s): Natasha B Leighl

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      Abstract not provided

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      PL02.09 - Nintedanib + Pemetrexed/Cisplatin in Patients with Unresectable MPM: Phase III Results from the LUME-Meso Trial (Now Available) (ID 11192)

      09:15 - 09:25  |  Presenting Author(s): Giorgio Vittorio Scagliotti  |  Author(s): Rabab Gaafar, Anna K. Nowak, Takashi Nakano, Jan Van Meerbeeck, Sanjay Popat, Nicholas Vogelzang, Federica Grosso, Rasha Aboelhassan, Marko Jakopovic, Giovanni L Ceresoli, Paul Taylor, Francisco Orlandi, Dean A Fennell, Silvia Novello, Arnaud Scherpereel, Ute Von Wangenheim, Miyoung Kim, José Barrueco, Anne S. Tsao

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      Background

      Nintedanib targets VEGFR 1–3, PDGFR α/β, FGFR 1–3, Src and Abl kinases, all implicated in malignant pleural mesothelioma (MPM) pathophysiology. This global Phase II/III, randomised, double-blind study investigated pemetrexed/cisplatin in combination with nintedanib or pemetrexed/cisplatin in combination with placebo, followed by nintedanib or placebo maintenance, in patients with unresectable MPM. In the double-blind, randomised Phase II part, nintedanib plus pemetrexed/cisplatin improved PFS vs placebo (HR=0.56; 95% CI: 0.34–0.91; p=0.017; median 9.4 vs 5.7 months).

      In Phase III, chemotherapy-naïve patients with epithelioid MPM (ECOG PS 0–1) were randomised 1:1 to receive up to six cycles of pemetrexed (500 mg/m2)/cisplatin (75 mg/m2) on Day 1, plus nintedanib (200 mg bid) or matched placebo on Days 2–21. After combination treatment, patients without disease progression received nintedanib or placebo maintenance. The primary endpoint (PFS by investigator assessment) and key secondary endpoint (OS) were planned to be analysed by hierarchical testing, with an interim OS analysis at the time of the primary PFS analysis. PFS was also assessed by independent central review. Based on the assumed treatment effect (HR=0.63), the study had 90% power to detect a statistically significant and clinically meaningful improvement in PFS.

      In total, 458 patients were randomised. Baseline patient characteristics and oncological history were similar between treatment arms. Median duration of nintedanib or placebo administration was 5.3 and 5.1 months, respectively. After 250 events, there was no difference in PFS between nintedanib and placebo arms (HR=1.01; 95% CI: 0.79–1.30; p=0.91; median 6.8 vs 7.0 months, respectively). PFS by central independent review was similar (242 events; HR=0.99; 95% CI: 0.77–1.28; p=0.96; median 6.8 months in each arm). In the interim OS analysis (127 deaths [28% of events]), median OS was 14.4 vs 16.1 months (nintedanib vs placebo; HR=1.12; 95% CI: 0.79–1.58; p=0.54). There were no unexpected safety findings. The proportion of patients with Grade ≥3 AEs was higher with nintedanib than with placebo (72% vs 62%). The most frequently reported Grade ≥3 AE by medical concept in both treatment arms was neutropenia (nintedanib: 32%; placebo: 24%). The proportion of deaths due to serious AEs was 4.0% (nintedanib) and 7.5% (placebo).

      The primary endpoint of the Phase III part of LUME-Meso was not met ‒ Phase II findings were not confirmed. The reported safety profile was consistent with the known safety profiles of nintedanib and pemetrexed/cisplatin.

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      PL02.10 - Discussant - PL02.09 (Now Available) (ID 14740)

      09:25 - 09:30  |  Presenting Author(s): Ross Soo

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      Abstract not provided

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